1. Field of the Invention
This invention pertains to the field of processing aloe plants and removing portions of said plant for processing same into compositions for topical and internal applications, and compositions of matter comprising said portions of aloe.
2. Description of the Prior Art, and Other Information
Approximately 325 species of Aloe are known, and most are indigenous to Africa. Aloe barbadensis is native to northern Africa, and was introduced into the island of Barbados about 1630. A variety of Aloe barbadensis (called Aloe chinensis Baker) was introduced by William Anderson into Curacao in 1817 from China. It was cultivated in Barbados for its laxative fraction until the middle of the nineteenth century, when the industry began to wane. Curacao aloe, which is often called Barbados aloe, comes from the Dutch islands of Aruba and Bonaire. The market for laxative aloe diminished as better and safer laxatives were developed.
The plant contains two separate juice materials. One is made from the clear cellular gel and the second, a yellow juice, is contained in the pericyclic cells of the vascular bundles located at the junction between the rind (cortex) and the internal fillet (FIGS. 1 and 2 - 1 is the clear cellular gel, 2 the yellow juice containing anthraquinones, 3 is the rind).
For centuries, the yellow juice has been dried and used as a laxative. For example, in the Dutch islands of Aruba and Bonaire, leaves are cut in March and April, then placed cut end downward on a V-shaped trough, which is inclined so that the latex can be fed into a cooking vessel. Varro E. Tyler, PHARMACOGNOSY at pp. 60-63 (Lea and Febiger, Philadelphia, 1981). The dried latex of the leaves of Aloe barbadensis Miller or other Aloes ranges in color from reddish-black to brownish-black to dark brown in color. The taste of each variety of dried latex is nauseating and bitter; also the odor is characteristic and disagreeable. It contains a number of anthraquinone glycosides; the principal one is called barbaloin (aloe-emodin anthrone C-10 glucoside). This dried latex, that has been sold for centuries as a laxative, is commonly called aloe or aloes. ##STR1##
The active laxative constituents vary quantitatively and qualitatively according to the species and environmental growing conditions. For example, Curacao aloe contains two and one half times as much aloe-emodin when compared to Cape Aloe, and Curacao aloe contains an appreciable amount of free chrysophanic acid not present in other types of aloe (Tyler, op. cit.). Many companies sell Aloe products that contain a large amount of the yellow sap even claiming them to be beneficial. Both juices become mixed together by the juice extraction process which is used by many producers. The following species of Aloe have been used commercially for their yellow sap, which was dried and used as a laxative. Arthur Osol et al., THE UNITED STATES DISPENSATORY AND PHYSICIANS' PHARMACOLOGY, (J. B. Lippencott Co., Philadelphia, 1980, at pp. 42-43:
1. Aloe Perryi Baker.--The true Socotrine aloe is a perennial herb, growing abundantly on the island of Socotra especially in the limestone tracts, from the sea level to an altitude of 3,000 feet and also found in eastern Africa and in Arabia. It has a trunk one foot high which bears on its summit a dense rosette of pale green or reddish, suc culent, lanceolate leaves with brown-tipped marginal spines. PA1 "2. Aloe barbadensis Mill.--(A. vera "L"; A. vulgaris Lamarck). This species, which is the source of Curacao aloe, has a very short, woody stem, and lanceolate embracing leaves, of glaucous green color, with hard, pale spi nes. It has bright yellow flowers arranged in a spicate inflorescence. A. barbadensis is a native of southeastern Europe, northern Africa, and Madagascar. It is cultivated in Italy, Sicily, Malta, and especially in the West Indies. PA1 "3. Aloe ferox Miller, one of the three South African, tree-like species yielding Cape aloe, is one of the tallest species of the genius. [sic]It has a forked stem 5 to 15 feet long, 4 to 6 inches in diameter; furnished at the top with a dense rosette containing 30 to 50 lanceolate leaves 1.5 to 2 feet long, with prickles. PA1 "4. Aloe africana Mill., an aborescent South African species, has a simple tall trunk which bears on its summit a few triangular-oblong, glaucous, green leaves with large, horny marginal teeth. It is a native of the Cape Colony. PA1 "5. Aloe spicata Baker. (A. Eru var. cornuta Berger) is a tall, branched aloe indigenous to tropical southern Africa. It possesses pale, glossy, fleshy leaves with white blotches and a panicle of campanulate yellow flowers." PA1 "The yellow sap has not been subjected to controlled clinical comparison with the other anthraquinones but has the reputation of being the most irritating of these cathartics. It produces considerable griping and pelvic congestion, and excessive doses may cause nephritis. It is still described in the U.S.P., but only for pharmaceutical reasons. Both aloe and aloin, a mixture of active glycosides, should be abandoned." PA1 1. They added a catalytic amount of a mild oxidant to fresh Aloe vera gel which is brought from about 35.degree. C. to about 80.degree. C. PA1 2. The preferred or oxidant material used for catalytic oxidation is hydrogen peroxide. PA1 3. Both prefer four to five year old plants. PA1 4. A non-toxic antioxidant is used to arrest catalytic oxidation, such as tocopherol. PA1 5. Their mild oxidation is allowed to take place for a period of time to oxidize completely certain gel substances believed to be beta globulin proteins and perhaps alpha globula proteins. PA1 6. Bill Coats used a commercially available extruder designed for orange juice processing in his process. PA1 7. Neither the Cobble nor Coats process collects and preserves the yellow sap. PA1 8. If the yellow sap contaminates the product, the disclosed process(es) provide(s) no means of removing it. PA1 9. Laboratory analysis of Aloe vera gel prepared by both the Coats and Cobble processes, revealed stabilized Aloe vera gel that varied hundreds of percent in yellow sap content, mineral content, color, taste, gel consistency and osmolarity (tonicity). PA1 (1) Gaurhari Mandal and Amalendu Das, "Structure of the Glucomannan Isolated from the Leaves of Aloe Barbadensis Miller", (Elsevier Scientific Publishing Company, Amsterdam, 1980) 87 at 249-256. PA1 (2) Gaurhari Mandal and Amalendu Das, "Structure of the D-Galactan Isolated from Aloe barbadensis Miller", (Elsevier Scientific Publishing Company, Amsterdam, 1980) 86 at 247-257. PA1 (3) Gaurhari Mandal, Rina Ghosh and Amalendu Das, "Characterisation of Polysaccharides of Aloe barbadensis Miller: Part III--Structure of an Acidic Oligosaccharide", (Indian Journal of Chemistry, September 1983) 22B at 890-893. Item (3) is not admitted to be prior art to the present invention. PA1 (a) washing an aloe leaf in a bactericidal solution to remove substantially all surface dirt and bacteria; PA1 (b) removing at least a first end portion from said washed leaf; PA1 (c) draining and collecting anthraquinone-rich sap from said cut and washed leaf; and PA1 (d) removing rind from said leaf to produce a substantially anthraquinone-free gel. PA1 (a) washing an aloe leaf in a bactericidal solution to remove substantially all surface dirt and bacteria; PA1 (b) removing a first end portion and a second portion from said washed leaf; PA1 (c) draining and collecting anthraquinone-rich sap from said washed and cut leaf; PA1 (d) removing rind from said leaf to produce a substantially anthraquinone-free aloe gel fillet; and PA1 (e) grinding and homogenizing said substantially anthraquinone-free aloe gel fillet to produce substantially anthraquinone-free juice. PA1 (1) A small pore size filter (preferably 100 Daltons) that separates out water and salts from the Aloe vera gel, if needed. PA1 (2) Larger pore size filters (preferably 500 Daltons) that can separate out the acids from the Aloe vera gel, if needed. PA1 (3) Even larger pore size filters (preferably 2,000 Daltons) that can separate the yellow sap components from the Aloe vera gel, if needed. PA1 (4) And even larger pore size filters (preferably from 10,000-100,000 Daltons that can size the gel matrix polymers, and divide them out by molecular weight. PA1 (a) washing an aloe leaf in a bacteriacidal solution to remove substantially all surface dirt and bacteria; PA1 (b) removing at least a first end portion from said washed leaf; PA1 (c) draining, preserving and collecting anthraquinone rich sap from said cut and washed leaf; PA1 (d) removing rind from said leaf to produce a substantially anthraquinone-free aloe gel fillet; PA1 (e) grinding and homogenizing said substantially anthraquinone-free aloe gel fillet to produce substantially anthraquinone-free aloe juice having solubilized matter; PA1 (f) adding a water soluble, lower aliphatic polar solvent to the aloe juice to precipitate the active chemical substance and thereby to form a heterogeneous solution; PA1 (g) removing the water soluble, lower aliphatic polar solvent and the solubilized matter from the heterogeneous solution to isolate the precipitated active chemical substance; and PA1 (h) drying the precipitated active chemical substance. PA1 (a) washing an aloe leaf in a bactericidal solution to remove substantially all surface dirt and bacteria; PA1 (b) removing rind from said leaf to produce an aloe gel fillet; PA1 (c) grinding and homogenizing said aloe gel fillet to produce aloe juice having solubilized matter; PA1 (d) adding a water soluble, lower aliphatic polar solvent to the aloe juice to precipitate the active chemical substance and thereby to form a heterogeneous solution; PA1 (e) removing the water soluble, lower aliphatic solvent and the solubilized matter from the heterogeneous solution to isolate the precipitated active chemical substance; and PA1 (f) drying the precipitated active chemical substance. PA1 1. No catalytic amount of a mild oxidant is used, thus preventing the oxidation of desirable constituents. PA1 2. The processes do not require heat, but can be performed at room temperature. PA1 3. Young, immature or damaged leaves can be used. PA1 4. An antioxidant does not have to be used to arrest catalytic oxidation. PA1 5. The beta gobulins and alpha globulins can be dialyzed out. PA1 6. Both hand and mechanical extruders can be used. PA1 7. The processes allow for the separate collection, storage and preservation of the yellow sap. (The yellow sap has been banned as a laxative, but it can be used as a sunscreen on undamaged skin. Plus, it provides a tan color to the skin.) PA1 8. If the yellow sap gets into the Aloe vera gel, it can be removed. PA1 9. It can provide Aloe vera gel that is standardized in its yellow sap content, mineral content, color, taste, gel consistency and osmolarity (tonicity). PA1 10. Individual components of Aloe vera gel can be isolated, dialyzed out and concentrated to concentrations many times greater than are found in the natural juice. PA1 11. Also, by separating out the fractions, new combinations of Aloe vera gel components are now attainable that heretofore did not exist in nature. PA1 12. In the event that too much preservative, flavoring or other GRAS substance is overadded, the batch can be saved in most cases by dialyzing out the excess. PA1 13. Selected Aloe components can be dialyzed out, chemically altered and then added back. PA1 14. Enzymes can be added to the Aloe gel, allowed to react and then separated out by ultrafiltration. PA1 The present invention finally provides a method for extracting the active chemical substance in Aloe vera gel. This active chemical substance shall hereinafter be referred to as CARRISYN.RTM. extract. As mentioned above, CARRISYN.RTM. extract has been found to be a substantially non-degradable lyophilized ordered linear polymer of acetylated mannose monomers which is measured and standardized both using analytical chemistry and bioassay techniques.
The current status of the yellow sap portion of Aloe as a laxative is best summarized by the text of Goodman and Gilman, as follows:
Goodman and Gilman, Eds., THE PHARMACOLOGICAL BASIS OF THERAPEUTICS, at 984, (MacMillan Publishing Co., Inc. New York 1975.)
Aloe is a tropical or subtropical plant characterized by lance-shaped leaves with jagged edges and sharp points. For centuries, this plant has been considered to have, and has been used for its medicinal and therapeutic properties without any clear understanding or scientific analysis of the basis for such properties. Note U.S. Pats. 3,892,853 to Cobble and 4,178,372 to Coats, both of which teach a process for producing an alleged stabilized (i.e. bacteriologically stable) aloe juice by extracting the mucilage from the aloe leaves and adding a mild oxidant (H.sub.2 O.sub.2). No reference is made in these patents to removing yellow sap, or to adverse properties in aloe juice due to the presence of yellow sap. In fact, both the `853 and `372 patents attribute adverse properties prior to processing to beta "and perhaps" alpha globulin proteins (col. 3, lines 41-43 of the `853; col. 3. lines 42-47 of the `372). Furthermore attempts to produce various commercial products from extracts and derivatives of the aloe plant have met with varying degrees of success and failure.